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A Study of LY573636 in Treating Patients With Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT00383292
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636 after one prior systemic treatment for unresectable or metastatic melanoma.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: LY573636 Phase 2

Detailed Description:
Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma
Study Start Date : November 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: LY573636
LY573636 dose is dependent on patient's height, weight, and gender and is adjusted to target a specific Cmax based on patient laboratory parameters. LY573636 is administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met.
Other Name: tasisulam



Primary Outcome Measures :
  1. Objective response rate (complete response + partial response). [ Time Frame: Baseline to measured progressive disease. ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Baseline to measured progressive disease. ]
  2. Clinical response rate (complete response plus partial response plus stable disease) [ Time Frame: Baseline to measured progressive disease. ]
  3. Pharmacokinetics [ Time Frame: Before and after each dose/infusion (Cycles 1 through 3). ]
  4. Overall survival time [ Time Frame: Baseline to date of death from any cause. ]
  5. Duration of overall objective response [ Time Frame: From time of response to time of measured progressive disease. ]
  6. Duration of stable disease [ Time Frame: Time from stable disease to time of measured progressive disease. ]
  7. Safety [ Time Frame: Every cycle. ]
  8. Health-related Quality of Life [ Time Frame: Every cycle. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
  • Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

Exclusion Criteria:

  • Serious pre-existing medical conditions
  • Have received two or more previous treatment regimens for unresectable or metastatic melanoma
  • Have a second primary cancer (unless disease-free to more than 2 years)
  • Active treatment with Warfarin (Coumadin)
  • Primary ocular or mucosal melanoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383292


Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90025
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, United States, 80045
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lakeland, Florida, United States, 33805
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202
United States, Minnesota
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rochester, Minnesota, United States, 55905
United States, New Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albuquerque, New Mexico, United States, 87131
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, United States, 38138
Australia, New South Wales
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Coffs Harbour, New South Wales, Australia, 2450
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wollongong, New South Wales, Australia, 2500
Australia, South Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Adelaide, South Australia, Australia, 5000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ashford, South Australia, Australia, 5035
Australia, Western Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00383292     History of Changes
Other Study ID Numbers: 10409
H8K-MC-JZAF ( Other Identifier: Eli Lilly and Company )
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas